A Pivotal Clinical Study to Investigate Efimosfermin Alfa in Participants With Biopsy-confirmed F2- or F3-stage MASH

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Non-alcoholic Fatty Liver Disease

In brief

The purpose of this study is to assess the safety and efficacy of efimosfermin alfa in the resolution of steatohepatitis and improvement of liver-related clinical outcome compared to placebo in individuals with MASH and biopsy-confirmed F2- or F3-stage fibrosis.

Key facts

Study ID

NCT07221227

Run by

GlaxoSmithKline

People needed

1200

Starts

2025-10-24

Expected to finish

2031-12-12

Last updated by the study team

2026-07-27

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Able and willing to understand and sign a written informed consent form that must be obtained prior to the initiation of study procedures
• Age >=18 and <=75 years at enrollment
• History or presence of 2 or more of the 5 components of metabolic syndrome per American Heart Association definition
• Liver biopsy confirmation of MASH consistent with stage F2 or F3 fibrosis and a NAS score >=4 confirmed by a central pathologist

You may not qualify if…

• Contraindication or ineligibility for percutaneous liver biopsy
• ALT or AST >=5 x upper limit of normal (ULN)
• Total bilirubin >=1.3 milligram per deciliter (mg/dL). Individuals with documented Gilbert's syndrome may be enrolled if they experienced an isolated increase in total bilirubin of >=1.3 mg/dL and direct bilirubin is <=20% of total bilirubin; otherwise, the individual will be excluded.
• Serum albumin <=3.5 grams per deciliter (g/dL)
• International normalized ratio (INR) >=1.3 not due to therapeutic anticoagulation. Individuals receiving chronic anticoagulant treatment with higher INR values may be enrolled at the discretion of the Investigator and Study Medical Monitor.
• Alkaline phosphatase (ALP) >=2*ULN
• Platelet (PLT) count <140,000 per (/) cubic millimeter (mm\^3); individuals with a PLT count between 110,000/mm\^3 and 140,000/mm\^3 may be enrolled after discussion with the Study Medical Monitor.
• Serum creatinine >=1.5 mg/dL or creatinine clearance <=60 milliliter (mL)/minute (min)/1.73 square meter by Chronic Kidney Disease Epidemiology Collaboration equation
• Alpha-fetoprotein >=20 nanogram per milliliter (ng/mL)
• Glycated hemoglobin >=9.0%
• Model for End-Stage Liver Disease score >=12 unless the score is elevated in the absence of liver dysfunction (e.g., Gilbert's syndrome)
• Phosphatidyl ethanol (PEth) >=80 ng/mL at Screening
• Evidence of infection with any of the following:
• Human immunodeficiency virus;
• Hepatitis B virus (detectable HBsAg at Screening);
• Hepatitis C virus (HCV);
• Chronic liver disease from any other cause including, but not limited to, alcoholic liver disease; evidence of portal hypertension; viral hepatitis or any history or evidence of cirrhosis on screening liver biopsy; or decompensated liver disease such as clinical ascites, bleeding gastroesophageal varices, hepatorenal syndrome, or hepatic encephalopathy prior to Screening or Day 1.
• Current or history of excessive alcohol intake for >=3 months within the 12-month period prior to Screening

Where it is running

• GSK Investigational Site — Tucson, Arizona, United States (enrolling)
• GSK Investigational Site — Little Rock, Arkansas, United States (enrolling)
• GSK Investigational Site — Arcadia, California, United States (enrolling)
• GSK Investigational Site — Covina, California, United States (enrolling)
• GSK Investigational Site — Folsom, California, United States (enrolling)
• GSK Investigational Site — Los Angeles, California, United States (enrolling)
• GSK Investigational Site — Montclair, California, United States (enrolling)
• GSK Investigational Site — Riverdale, California, United States (enrolling)
• GSK Investigational Site — San Diego, California, United States (enrolling)
• GSK Investigational Site — Santa Maria, California, United States (enrolling)
• GSK Investigational Site — Van Nuys, California, United States (enrolling)
• GSK Investigational Site — Colorado Springs, Colorado, United States (enrolling)
• GSK Investigational Site — Boynton Beach, Florida, United States (enrolling)
• GSK Investigational Site — Cape Coral, Florida, United States (enrolling)
• GSK Investigational Site — Clermont, Florida, United States (enrolling)
• GSK Investigational Site — Fort Myers, Florida, United States (enrolling)
• GSK Investigational Site — Hialeah, Florida, United States (enrolling)
• GSK Investigational Site — Hialeah, Florida, United States (enrolling)
• GSK Investigational Site — Homestead, Florida, United States (enrolling)
• GSK Investigational Site — Inverness, Florida, United States (enrolling)
• GSK Investigational Site — Jacksonville, Florida, United States (enrolling)
• GSK Investigational Site — Kissimmee, Florida, United States (enrolling)
• GSK Investigational Site — Lakeland, Florida, United States (enrolling)
• GSK Investigational Site — Maitland, Florida, United States (enrolling)
• GSK Investigational Site — Chandler, Arizona, United States (enrolling)

Full record on ClinicalTrials.gov

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